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View Full Version : Medical device functional test - ISO 2859 or 3951


Palt88
2nd March 2009, 12:11 PM
Dear all,

I know the C=0 and ISO 2859 tables.
Actually we have a customer that start to speak about the 3951 choice for a Medical device functional testing (a simple force activation measurement).

I don't know this table. Could someone is able to simply explain me in which main cases the 3951 is mandatory instead of the 2859 ?

By reading a little bit, and if I understand well:
- the 3951 table check for mean or standard deviation, and the lot is rejected if the sampling is out of a certain % ?
- this table could only apply to a sequential testing ?
- Is this table is more used in pharma for concentration or other things than physical properties of a medical device ?

Well if you can make things a little bit clear for me....

Thanks in advance
Fred

Coury Ferguson
3rd March 2009, 04:24 PM
Can anyone help?

Palt88
5th March 2009, 04:28 AM
Yes I'm still struggling a bit.

In fact I'm unable to find any concrete exemple on the net.

The 3951 seems to be well known, butI would like to know if practically iit is almost never used due to it's incovenient (computing, sampling in-spec rejected, etc...)

Well, if someone can tell me: forget that one!

Palt88
25th March 2009, 08:08 AM
Nobody is using the 3951 ? :confused: